EP0766972B1 - Medical instrument - Google Patents
Medical instrument Download PDFInfo
- Publication number
- EP0766972B1 EP0766972B1 EP96111262A EP96111262A EP0766972B1 EP 0766972 B1 EP0766972 B1 EP 0766972B1 EP 96111262 A EP96111262 A EP 96111262A EP 96111262 A EP96111262 A EP 96111262A EP 0766972 B1 EP0766972 B1 EP 0766972B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- blood
- parts
- hexafluoropropylene
- medical
- vinylidene fluoride
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/06—Use of macromolecular materials
- A61L33/064—Use of macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
Definitions
- the invention relates to medical tools such as catheters, Hoses, containers, molded parts and the like made of polymeric materials, wherein these tools have special equipment to increase the Blood compatibility when in contact with blood or blood-like Have liquids.
- a coated catheter is known from DE-A 19 30 136, which as the basis of a hose made of rubber or an elastomer.
- This catheter tube is on the outer and / or inner wall with a hydrophilic polyacrylate or methacrylate, especially with a Hydroxykyl- or a Hydroxialkoxi-alkyl acrylate or methacrylate coated with lower alkyl residues.
- DE 31 53 664 C2 describes the use of polysiloxane-polyurethane block copolymers known to the Surface properties of surfaces in contact with blood of modifying biomedical device setup.
- This Block copolymers themselves have poor structural features due to the high content of polysiloxane. They are also expensive Raw materials and complex manufacturing or coating processes.
- DE 19 44 969 A1 also describes the use, inter alia, of of polyurethanes (Urethane-siloxane polymers) known, which together with a polysiloxane Form block copolymers.
- Draw these block copolymers are characterized by high mechanical stability and can be used in films or Plates are poured. They also have high blood tolerance and are therefore suitable for the surfaces of molded parts that come into contact with blood. The usability for coatings is however limited or not available.
- EP 0 334 062 A2 describes the use of polycaprolactome polymers known for medical articles, the surface of which is compatible with blood Coating thus has. With these coatings prevents the formation of blood clots, for example. Further is from EP 0 261 470 A1 a comparable application of polycaprolactome polymers and from EP 0 068 385 B1 a use of polyurethane-silicone polymers for those directly contacted with blood Molded parts known.
- the invention is based on the consideration of the starting polymer additives add the material with blood compatibility approach its relative coagulation parameter to the quotient 1.0.
- copolymers according to the invention can be used as working agents Complement or replace working aids such as lubricants and the like.
- the medical equipped with the copolymers according to the invention Tools prevent platelet aggregation and deactivate intrinsic coagulation. Pre-sterilization of the semi-finished products is no longer necessary since the copolymers according to the invention counter the heparin coating previously used is no longer microbially degraded can be.
- Soft PVC formulation 100 Parts S-PVC 10-90 Parts of organic plasticizer 1-10 Parts of epoxidized oils 0.1-1.0 Parts of metal soaps 0.1-0.6 Parts of lubricant 0.1-2 Parts of hexafluoropropylene-vinylidene fluoride copolymer
- Polyurethane formulation 100 Parts of polyurethane 0.1-1.5 Parts of hexafluoropropylene-vinylidene fluoride copolymer
- Polypropylene recipe 100 Parts of polypropylene 1.0-3 Parts of metal soaps 0.1-2 Parts of hexafluoropropylene-vinylidene fluoride copolymer
Description
Die Erfindung betrifft medizinische Arbeitsmittel wie Katheter, Schlauche, Behälter, Formteile und dergleichen aus polymeren Materialien, wobei diese Arbeitsmittel eine besondere Ausstattung zur Erhöhung der Blutkompatibilität bei der Berührung mit Blut oder blutähnlichen Flüssigkeiten aufweisen.The invention relates to medical tools such as catheters, Hoses, containers, molded parts and the like made of polymeric materials, wherein these tools have special equipment to increase the Blood compatibility when in contact with blood or blood-like Have liquids.
Aus der DE-A 19 30 136 ist ein beschichteter Katheter bekannt, welcher als Basis aus einem Schlauch aus Gummi oder einem Elastomeren besteht. Dieser Katheterschlauch ist an der Außen- und/oder Innenwand mit einem hydrophilen Polyacrylat bzw. -Methacrylat, insbesondere mit einem Hydroxialkyl- oder einem Hydroxialkoxi-Alkyl-Acrylat bzw. -Methacrylat mit jeweils niederen Alkylresten beschichtet.A coated catheter is known from DE-A 19 30 136, which as the basis of a hose made of rubber or an elastomer. This catheter tube is on the outer and / or inner wall with a hydrophilic polyacrylate or methacrylate, especially with a Hydroxykyl- or a Hydroxialkoxi-alkyl acrylate or methacrylate coated with lower alkyl residues.
Weiterhin ist es bekannt, derartige medizinische Arbeitsmittel mit einer Beschichtung aus Heparin zu versehen. Diese Heparin-Beschichtungsverfahren arbeiten über APTES- und TDMAC-Brücken. Mit dieser Heparin-Beschichtung wird das Anhaften von Blutplättchen an der Oberfläche des medizinischen Arbeitsmittels verhindert und gleichzeitig die intrinsische Koagulation desaktiviert. Ausführungen zum Beschichtungsverfahren mit Heparin über TDMAC-Brücken finden sich bei G.A. Grode, R.D. Falb, J.P. Crowley in J. Biomed. Mater. Res. Symp., 3.77 (1972). Entsprechende Hinweise zur Beschichtung mit Heparin über APTES-Brücken finden sich bei R.L. Merker, L.J. Elyasch, S.W. Mayhew, J.Y.C. Wang in Proc. Artif. Heart Conf., 1969, Seite 29.Furthermore, it is known to use such medical tools to provide a coating made of heparin. This heparin coating process work over APTES and TDMAC bridges. With this heparin coating becomes the adherence of platelets to the surface of the medical work equipment prevented and at the same time the intrinsic Coagulation deactivated. Comments on the coating process with heparin over TDMAC bridges can be found at G.A. Grode, R.D. Falb, J.P. Crowley in J. Biomed. Mater. Res. Symp., 3.77 (1972). Appropriate Instructions for coating with heparin over APTES bridges can be found at R.L. Merker, L.J. Elyasch, S.W. Mayhew, J.Y.C. Wang in Proc. Artif. Heart Conf., 1969, page 29.
Alle diese Verfahren haben den prinzipiellen Nachteil, daß sie technisch aufwendig und sehr arbeitsintensiv sind. So läuft eine Heparinisierung bei beiden genannten Verfahren in mehreren zusätzlichen Arbeits- und Beschichtungszyklen ab.All of these processes have the fundamental disadvantage that they are technical are complex and very labor intensive. This is how heparinization works in both of these methods in several additional work and coating cycles.
Ein weiterer wesentlicher Nachteil dieser bekannten Verfahren ist, daß die auf diese Weise hergestellten medizinischen Halbzeuge sterilisiert werden müssen, weil die Beschichtung mit Heparin mikrobiell abgebaut werden kann. Da nach der Konfektion der Halbzeuge zu Fertigprodukten eine Gesamtsterilisation erforderlich ist, ist hier als weiterer Nachteil das erhebliche Risiko einer Mehrfachsterilisation zu nennen.Another major disadvantage of these known methods is that sterilize the medical semi-finished products produced in this way must be degraded because the coating with heparin is degraded microbially can be. Since after the semi-finished products are made into finished products total sterilization is required is another disadvantage here mention the considerable risk of multiple sterilization.
Neben der Verwendung von Heparin ist aus der DE 31 53 664 C2 die Verwendung von Polysiloxan-Polyurethan-Blockcopolymeren bekannt, um die Oberflächeneigenschaften von mit Blut in Berührung stehenden Oberflächen von Einrichtung biomedizinischer Geräte zu modifizieren. Diese Blockcopolymere haben selbst schlechte strukturelle Merkmale aufgrund des hohen Gehaltes an Polysiloxan. Außerdem handelt es sich um teure Rohstoffe und aufwendige Herstellungs- bzw. Beschichtungsverfahren.In addition to the use of heparin, DE 31 53 664 C2 describes the use of polysiloxane-polyurethane block copolymers known to the Surface properties of surfaces in contact with blood of modifying biomedical device setup. This Block copolymers themselves have poor structural features due to the high content of polysiloxane. They are also expensive Raw materials and complex manufacturing or coating processes.
Weiter ist aus der DE 19 44 969 A1 die Verwendung u.a. von Polyurethanen (Urethan-Siloxan-Polymeren) bekannt, welche zusammen mit einem Polysiloxan Blockmischpolymere bilden. Diese Blockmischpolymere zeichnen sich durch hohe mechanische Stabilität aus und können in Filme oder Platten gegossen werden. Sie besitzen außerdem eine hohe Blutverträglichkeit und eignen sich daher für die Oberflächen von Formteilen, die mit Blut in Berührung kommen. Die Verwendungsfähigkeit für Beschichtungen ist allerdings begrenzt bzw. nicht gegeben.DE 19 44 969 A1 also describes the use, inter alia, of of polyurethanes (Urethane-siloxane polymers) known, which together with a polysiloxane Form block copolymers. Draw these block copolymers are characterized by high mechanical stability and can be used in films or Plates are poured. They also have high blood tolerance and are therefore suitable for the surfaces of molded parts that come into contact with blood. The usability for coatings is however limited or not available.
Aus der EP 0 334 062 A2 ist die Verwendung von Polycaprolactom-Polymeren bei medizinischen Artikeln bekannt, deren Oberfläche eine blutverträgliche Beschichtung damit aufweist. Mit diesen Beschichtungen wird beispielsweise das Entstehen von Blutgerinnseln verhindert. Ferner ist aus der EP 0 261 470 A1 eine vergleichbare Anwendung von Polycaprolactom-Polymeren und aus der EP 0 068 385 B1 eine Verwendung von Polyurethan-Silikon-Polymeren für unmittelbar mit Blut in Kontakt gebrachte Formteile bekannt.EP 0 334 062 A2 describes the use of polycaprolactome polymers known for medical articles, the surface of which is compatible with blood Coating thus has. With these coatings prevents the formation of blood clots, for example. Further is from EP 0 261 470 A1 a comparable application of polycaprolactome polymers and from EP 0 068 385 B1 a use of polyurethane-silicone polymers for those directly contacted with blood Molded parts known.
Obwohl diese Vorveröffentlichungen die antithrombotische Behandlung von medizinischen Artikeln beschreiben, ist zum einen die optimale Blutkompatibilität nicht gegeben und zum anderen handelt es sich um arbeitsaufwendige und damit kostenintensive Verfahrensweisen. Although these prior publications disclose the antithrombotic treatment of Describing medical articles is on the one hand the optimal blood compatibility not given and on the other hand it is labor-intensive and therefore costly procedures.
Hier setzt die Erfindung ein, die es sich zur Aufgabe gestellt hat, die zum Stand der Technik genannten Nachteile zu vermeiden und eine Methode zur Erzielung der optimalen Blutkompatibilität bei medizinischen Halbzeugen aufzuzeigen, bei der über das medizinische Arbeitsmittel weder das biologische System negativen Auswirkungen ausgesetzt ist noch das Material, aus dem das medizinische Arbeitsmittel gefertigt ist, durch Einwirkung des biologischen Systems so weit geschädigt werden kann, daß es die vorgesehene Funktion nicht mehr erfüllt. Erfindungsgemäß wird dazu vorgeschlagen, daß in das Ausgangspolymere vor der eigentlichen Formgebung eine definierte Menge eines Copolymeren aus Hexafluor-Propylen und Vinylidenfluorid mit einem mittleren Molekulargewicht von wenigstens 70.000 eingemischt ist.This is where the invention comes in, which has set itself the task of to avoid disadvantages mentioned in the prior art and a method to achieve optimal blood compatibility in medical semi-finished products to show in the case of the medical equipment neither the biological system is still exposed to negative effects Material from which the medical equipment is made by Influence of the biological system can be damaged so far that it no longer fulfills the intended function. According to the invention proposed that in the starting polymer before the actual Shaping a defined amount of a copolymer from hexafluoropropylene and vinylidene fluoride with an average molecular weight of at least 70,000 is mixed in.
Die Erfindung geht von der Überlegung aus, dem Ausgangspolymeren Additive zuzusetzen, die den Werkstoff von der Blutkompatibilität her mit seinem relativen Gerinnungsparameter dem Quotienten 1,0 annähern.The invention is based on the consideration of the starting polymer additives add the material with blood compatibility approach its relative coagulation parameter to the quotient 1.0.
Dieses Vorhaben ist durch die erfindungsgemäße Zugabe von Hexafluor-Propylen-Vinylidenfluorid-Copolymeren gelungen. So hat es sich bei der Verwendung von weichmacherhaltigem Polyvinylchlorid als Ausgangsmaterial für die Herstellung medizinischer Arbeitsmittel als vorteilhaft herausgestellt, daß die heute für solche Anwendungszwecke üblichen PVC-Rezepturen auf Basis Zink und Kalzium erfindungsgemäß durch die genannten Copolymere ergänzt werden. Hierbei hat sich als zweckmäßig eine Dosierungsrate von 0,1 bis 2,0 Gewichtsprozent erwiesen.This project is due to the addition of hexafluoropropylene-vinylidene fluoride copolymers according to the invention succeeded. So it was with the Use of plasticized polyvinyl chloride as the starting material as advantageous for the production of medical equipment emphasized that the PVC formulations common today for such applications based on zinc and calcium according to the invention by the aforementioned Copolymers are supplemented. A dosage rate has been found to be expedient here proven from 0.1 to 2.0 weight percent.
Bei der Verwendung anderer Polymere zur Herstellung der medizinischen Arbeitsmittel können die erfindungsgemäßen Copolymere die eingesetzten Arbeitshilfen wie Gleitmittel und dergleichen ergänzen oder ersetzen.When using other polymers to make the medical The copolymers according to the invention can be used as working agents Complement or replace working aids such as lubricants and the like.
Die mit den erfindungsgemäßen Copolymeren ausgestatteten medizinischen Arbeitsmittel verhindern die Blutplättchen-Aggregation und desaktivieren die intrinsische Koagulation. Eine Vorsterilisierung der Halbzeuge ist nicht mehr erforderlich, da die erfindungsgemäßen Copolymere entgegen der bisher üblichen Heparinbeschichtung nicht mehr mikrobiell abgebaut werden können.The medical equipped with the copolymers according to the invention Tools prevent platelet aggregation and deactivate intrinsic coagulation. Pre-sterilization of the semi-finished products is no longer necessary since the copolymers according to the invention counter the heparin coating previously used is no longer microbially degraded can be.
Die nachfolgenden Beispiele zeigen die Verwendungsmöglichkeit der erfindungsgemäßen Copolymere als Zuschlagstoffe für polymere Materialien zur Herstellung medizinischer Arbeitsmittel.The following examples show the possible uses of the invention Copolymers as additives for polymeric materials for the production of medical equipment.
Claims (2)
- Medical equipment such as catheters, hoses, vessels, mouldings made of polymeric materials, in which this equipment is specially furnished to increase the blood compatibility on contact with blood or liquids similar to blood, characterised by: a defined quantity of a co-polymer consisting of hexafluoropropylene and vinylidene fluoride with an average molecular weight of at least 70,000 is added to the initial polymers before the actual moulding.
- Medical equipment as described in Claim 1, characterised by: the quantity of hexafluoropropylene/vinylidene fluoride co-polymer lies between 0.1 and 2.0 percent by weight.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19533245A DE19533245C1 (en) | 1995-09-08 | 1995-09-08 | Medical device, esp. catheter, hose, container or moulding |
| DE19533245 | 1995-09-08 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| EP0766972A2 EP0766972A2 (en) | 1997-04-09 |
| EP0766972A3 EP0766972A3 (en) | 2000-02-02 |
| EP0766972B1 true EP0766972B1 (en) | 2002-02-13 |
Family
ID=7771630
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP96111262A Expired - Lifetime EP0766972B1 (en) | 1995-09-08 | 1996-07-12 | Medical instrument |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP0766972B1 (en) |
| DE (2) | DE19533245C1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7621884B2 (en) | 2002-03-20 | 2009-11-24 | Gambro Lundia Ab | Tube for medical applications and circuit incorporating such tube |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10239738A1 (en) * | 2002-08-29 | 2004-03-18 | Rehau Ag + Co. | Material for use in tubing, sealing elements and moldings to avoid the allergenic properties of natural rubber consists predominantly of PVC, plasticizer, amide wax and synthetic rubber |
| DE102016210106A1 (en) * | 2016-06-08 | 2017-12-14 | Raumedic Ag | Material composition for a hose body and hose with a hose body with such a composition |
| WO2017211870A1 (en) | 2016-06-08 | 2017-12-14 | Raumedic Ag | Material composition for a hose body and hose having a hose body having such a composition |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3730797A1 (en) * | 1987-09-14 | 1989-03-23 | Siegel Rolf | Materials having a non-thrombogenic surface |
| EP0334062B1 (en) * | 1988-03-24 | 1994-05-18 | American Cyanamid Company | Bioabsorbable coating for a surgical article |
| GB9026687D0 (en) * | 1990-12-07 | 1991-01-23 | Vascutek Ltd | Process for providing a low-energy surface on a polymer |
-
1995
- 1995-09-08 DE DE19533245A patent/DE19533245C1/en not_active Expired - Fee Related
-
1996
- 1996-07-12 EP EP96111262A patent/EP0766972B1/en not_active Expired - Lifetime
- 1996-07-12 DE DE59608724T patent/DE59608724D1/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7621884B2 (en) | 2002-03-20 | 2009-11-24 | Gambro Lundia Ab | Tube for medical applications and circuit incorporating such tube |
Also Published As
| Publication number | Publication date |
|---|---|
| DE19533245C1 (en) | 1996-10-10 |
| DE59608724D1 (en) | 2002-03-21 |
| EP0766972A3 (en) | 2000-02-02 |
| EP0766972A2 (en) | 1997-04-09 |
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